Medical devices are typically sterilized prior to use. Most medical devices are packaged in packaging which maintains the sterility of the device until the package is opened by the health care provider at the site where the health care services are being administered or provided. Depending upon the environment in which the devices are used, it is possible for the device to be contaminated with microbes prior to use or during insertion, or after insertion or implantation if the implantation site in the patient is contaminated, for example as a result of trauma or faulty or inadequate sterile procedures. Microbial contamination of medical devices can result in serious infections in the patient which are often not easily treatable for a variety of reasons, including the formation of antibiotic resistant biofilms. The use of antimicrobial coatings on medical devices may eliminate or diminish the incidence of infections associated with the use or implantation of medical devices. In addition to bacterial contamination and tissue infection, many postsurgical complications are caused by excess tissue inflammation, leading to pain and edema at the surgical or implant site, scarring and tissue adhesion.
Using a galvanic couple as the power source in iontophoresis patch devices is known in the art. See, for example, U.S. Pat. Nos. 5,147,297, 5,162,043, 5,298,017, 5,326,341, 5,405,317, 5,685,837, 6,584,349, 6,421,561, 6,653,014, and U.S. Patent Application US 2004/0138712. The galvanic couple is made from powders of dissimilar metals, such as a zinc donor electrode and a silver chloride counter electrode. Some of these galvanic couple powered topical iontophoresis patch devices activate automatically when body tissue and/or fluids form a complete circuit with the galvanic system to generate the electricity. These devices are applied to the human body in order to provide an intended benefit, such as electrical stimulation, enhanced wound healing, or antimicrobial treatment. Other types of topical systems powered by galvanic couples its the form of particulates are disclosed in U.S. Pat. Nos. 7,476,221, 7,479,133, 7,477,939, 7,476,222, 7,477,940, and U.S. Patent Applications US 2005/0148996 and US 2007/0060862, which have, inter alia, disclosures directed toward topical treatments of skin and mucosal tissues.
The aforementioned galvanic treatment systems have been recognized as being useful in topical therapeutic products for the skin, nails, hair and mucosal conditions and diseases. There is a need in this art for novel implantable medical devices that have enhanced antimicrobial properties while retaining the biocompatible nature and mechanical functionality of the device, and which may have additional advantages such as anti-inflammatory and tissue regenerative properties.